Legislative Updates

Legislative Updates:Current through July 31, 2014

Public Chapter 949
This act allows for initial licensure applications to be accepted online. Currently, renewing licenses is already available online. This also makes available to the public annual inspections of health care facilities and pharmacies, similar to how nursing home inspections are already available.

Public Chapter 622
Current law requires that, prior to writing a script for an opiate or benzodiazepine; a practitioner must check the database for their patient. This act allows that patient’s profile to be placed in their medical record, which is subject to HIPAA. This further allows the Department of Health to make available upon request aggregate, de-identified data from the CSMD.

Public Chapter 623
Naloxone is an opioid antagonist designed to stop the effects of an opiate related overdose. This act allows a licensed healthcare practitioner to prescribe naloxone to a person at risk of having an opiate related overdose, or a family member or friend of the at-risk individual. It further requires training in administration of naloxone prior to the drug being prescribed. Civil immunity is provided for both the prescribing practitioner and the individual administering naloxone.

Public Chapter 585
This legislation allows the Commissioner of Health to set the pharmacy formulary for medications that are issued from local health departments. It allows input from the Board of Pharmacy on the medications to be listed. This will streamline the process and allow for more prompt changes to the formulary.Public Chapter 763
This act revises delinquent privilege tax provisions that would require the Department of Revenue to notify the licensee that failure to cure the delinquency or deficiency prior to their licensure renewal date can result in renewal abeyance. For purposes of the bill, “cure” means payment in full, entering into an agreed payment plan, or abatement of tax liability. Licensing boards will be provided monthly with list of licensees who are delinquent 90 days or more and boards may not process licensure renewal.

This is the Methamphetamine Production Reduction Act. The law caps the sale/purchase of ephedrine or pseudoephedrine products at 5.76 g/month or 28.8 g/year, per person requiring prescription. The caps shall not apply with respect to a valid prescription from a practitioner authorized to prescribe. No person under the age of 18 may purchase the products except pursuant to a valid prescription from a practitioner or from a pharmacist generated prescription.

Public Chapter 983
This is a pain clinic revision act that requires all healthcare practitioners to notify their appropriate licensing board within 10 days of starting or ending employment at a pain clinic. It prevents health care prescribers from dispensing an opioid or benzodiazepine except under certain conditions. Requires all opioids and benzodiazepine’s not falling under the exemptions to be returned to a reverse distributor or to local law enforcement by Jan. 11, 2015. The act requires pharmacy wholesalers to notify the Board of Pharmacy and other prescribing boards when suspicious orders (unusual size, deviations from normal pattern, and unusual frequency) are discovered. Wholesalers must report a theft or significant loss of controlled substances to the Controlled Substance Monitoring Committee and local law enforcement within one business day of discovery.

Public Chapter 575
This act extends civil immunity to health care providers providing services at clinics that charge patients based on a sliding scale to health care providers offering services at a clinic that does not charge a patient for services.

Public Chapter 872
This act requires an individual picking up prescription of a schedule II-IV opioid, benzodiazepine, zolpidem, barbiturate, or carisoprodol to show identification. The individual picking up the prescription is not required to be the person for whom the script is written for. Several exemptions apply to this law such as: it is only applicable to prescriptions longer than a 7-day period; dispenser is not required to check ID if the person is personally known by dispenser; minors or homeless individuals that do not have ID may receive prescription based upon dispenser’s personal judgment; does not apply to veterinarians; does not apply to samples dispensed by healthcare professionals. Additionally, this act does not apply to scripts written for: inpatients in a hospital; outpatients of a hospital where prescriber writes order in medical chart and order is given directly to hospital pharmacy; residents of a nursing home or assisted living facility; inpatients or residents of licensed MH facility; inpatients or residents of a DEA registered narcotic treatment program; patients in correctional facilities; mail order patients; pharmacy home delivery patients. Violations of this act are only subject to civil penalty assessed by the licensing board, which is authorized to promulgate rules to effectuate this act.

Public Chapter 828
This requires a pharmacy to submit a data entry error correction to the NPLEx, upon learning of a data entry error. It prohibits the NPLEx from generating a stop sale alert where quantity limit is exceeded due to data entry error for which a correction was submitted.

Public Chapter 857
This act defines maximum allowable cost (MAC) and maximum allowable cost list for pharmacy benefits managers (PBM) and covered entities and requires PBM to find that a drug is generally available for purchase by pharmacies in the state from a national or regional wholesaler, prior to that drug being placed on MAC list. If a drug on the MAC list no longer meets these qualifications, it must be removed from list within 5 business days after discovery. This act does not prohibit a PBM from reimbursing claims for generics at a previously determined MAC, even if a PBM reimburses brand name at contracted rate after drug is determined generally unavailable. PBM’s must make available to each pharmacy contracted with or included in their network, at the beginning of the contract and upon renewal, the following: sources used to determine MAC for drugs and devices on MAC list; every MAC for individual drugs used by PBM for patients served by that pharmacy; and, upon request, every MAC list used by that PBM for patients served by that pharmacy. PBM’s shall: update the MAC list at least every 3 business days; make updated lists available to each pharmacy contracted with or included in network, online; and, utilize updated MACs to calculate payments made to pharmacies within 5 business days. PBM’s shall define how a pharmacy may contest the MAC of a particular drug or device. Pharmacies may appeal if the MAC established is below the cost of that drug or product is generally available and/or the PBM has placed the drug on list without determining that the drug is generally available for purchase by pharmacies in the state from a national or regional wholesaler. The appeal must be filed within 7 business days of submission of initial claim for reimbursement. A PBM must make its final determination of appeal within 7 business days of PBM receiving the appeal. Any denial of appeal requires the PBM to state the reason for denial and provide national drug code of equivalent drug that is generally available for purchase at a price which is equal to or less that MAC for drug. Successful appeals require the PBM to adjust MAC of drug or device for appealing pharmacy, effective from the date the appeal was filed, and within 3 business days to apply to claims submitted by other network pharmacies for the next payment cycle. PBM’s shall make information regarding the appeals process available online. Medical products and devices are limited to those included as pharmacy benefit under the contract. Violations of this law may subject PBM’s to current penalties in law. Pharmacies shall not disclose to any third party any MAC lists or other related information it receives from a PBM except that pharmacies may share such lists and information with pharmacy services administrative organizations or similar entities which the pharmacy contracts with to provide administrative services. Organizations that receive such information from pharmacies shall not disclose the information to any third party. This act takes effect January 1, 2015 and applies to all contracts entered into or renewed on or after that date.

Public Chapter 832
This authorizes collaborative pharmacy practice agreements (CPPAs) and sets out the legal parameters for CPPAs involving pharmacists and health care practitioners with prescriptive authority. It prohibits a retail pharmacy from employing an individual with prescribing authority for the purpose of maintaining, establishing or entering into a collaborative practice agreement with a patient. Further, it specifies that nothing shall prevent a pharmacy or pharmacist or group of pharmacists from employing or entering into a professional contract with a physician or licensed medical practitioner for the purpose of conducting quality assurance reviews of its pharmacists that are engaged in the practice of collaborative drug therapy.

Public Chapter 1011
The act requires submissions to the Controlled Substance Monitoring Database be made at the close of each business day for all controlled substances dispensed the prior business day. The act does provide good faith effort exemption and gives the Board of Pharmacy the ability to make rules implementing this exemption.

Statutes and Rules

Statutes

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§ Title - Chapter - Part

Pharmacy Practice § 63 - 10 - 201
Board of Pharmacy § 63 - 10 - 301

Once you have entered LexisNexis Law web site, on the left side of the page, next to Tennessee Code, change the plus sign to a negative sign by clicking on the plus sign. Then scroll down to the bottom of the page and click on the plus sign next to "More…" again changing the plus sign to a negative sign. Continue scrolling down and click on the plus sign next to Title "XX" you want to preview (For you convenience we have listed some of the most popular Titles and Chapters above). Finally, scroll down and click on the plus sign next to the specific Chapter "XX" you want to preview. Highlight the actual words of that Chapter by clicking on it and the law will displayed on the right side of the page for you to review.

To print the Law; on the left side of the page, click in the box next to Chapter "XX", a check mark will display in the box. If you change the plus sign to a negative sign by clicking on the plus sign next to Chapter "XX" you will notice check marks in all the documents below that Chapter, which means you have chosen to print all the Parts within the Chapter. If you only want to print a certain document, place a check mark on that Part only. For example, to print the Beauty Pageants Law, Bonded Credit Services Law or Health Clubs Law only, on the left side of the page, click in the box next to their specific Part "XX" listed under Chapter 18. Then go to the top of the right side of the page and click on Print. This will print only the documents chosen in the table of contents. Click Here to go to LexisNexis Law website.

Rules

Click here for Rules and Regulations pertaining to the Tennessee Board of Pharmacy